Regulatory Affairs Manager

Katalyst CRO; Menlo Park (CA); On-site; USD 100,000 - 150,000; Full time

Job summary

A leading contract research organization is seeking a Regulatory Affairs Manager to oversee regulatory compliance and interactions with health authorities. The role involves developing regulatory strategies, preparing documentation for submissions, and ensuring the organization meets all legal requirements while collaborating with various internal teams.

Qualifications

• 5+ years of experience in Regulatory Affairs within biotech or pharma industries.
• Strong analytical, problem-solving, and communication skills.

Responsibilities

• Managing the company's regulatory interface with domestic and international health authorities.
• Developing and deploying regulatory programs to ensure product approval.
• Preparing and submitting regulatory documents for new products and changes to existing filings.

Skills

Analytical skills

Problem-solving

Communication skills

Education

Bachelor's or advanced degree in a scientific discipline

Job description

Join to apply for the Regulatory Affairs Manager role at Katalyst CRO.

Responsibilities include:

• Managing the company's regulatory interface with domestic and international health authorities.
• Developing and deploying regulatory programs to ensure product approval.
• Preparing and submitting regulatory documents for new products and changes to existing filings.
• Managing clinical study submissions.
• Ensuring compliance with governmental regulations affecting company processes.
• Collaborating with teams across the organization (Clinical Operations, R&D, Quality, etc.).
• Guiding localization and labeling requirements.
• Managing regulatory reporting.

Requirements:

• Bachelor's or advanced degree in a scientific discipline (M.S., Pharm.D., M.D., Ph.D.) preferred.
• 5+ years of experience in Regulatory Affairs within biotech or pharma industries.
• Strong analytical, problem-solving, and communication skills.

Additional Details:

• Seniority level: Mid-Senior level
• Employment type: Contract
• Job function: Legal
• Industry: Pharmaceutical Manufacturing